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424 Chapter 42 Radiofrequency treatment of the incompetent saphenous vein
https://t.me/med1917
an adequate treatment to the vein wall. A thermocouple
located on the electrodes monitored the temperature and
provided continuous feedback to a generator, which, in turn,
adjusted power delivery to maintain a temperature of either
85°C or 90°C. With widely accepted clinical success notwithstanding, the rst-generation CP catheter suffered from
very slow treatment times in comparison to laser ablation.
Because of the necessarily slow catheter pullback speeds
and not infrequent generator “shut-offs” when impedance surpassed a predetermined threshold, treatment times
would often exceed 30 minutes. Additionally, results were
occasionally inconsistent because of poor contact between
the electrodes and the vein wall, with either ineffective closure of the saphenous vein or early recanalization.
42.1 Bipolar heating element design of the original ClosurePlus
device.
In 2007, the current-generation CLF segmental ablation catheter replaced the bipolar electrode catheter. The
CLF catheter has a 7-cm heating element at its tip, which
is heated to 120°C by RF energy supplied through an RF
generator (RFG) (Figure 42.2). During energy delivery, the
catheter remains stationary for a period of 20 seconds. By
conductive heat transfer
, the vein wall segment in contact
with the 7-cm catheter heating element reaches a temperature of 100–110°C. The catheter is then moved distally in
6.5-cm increments, thus achieving a 0.5-cm treatment overlap zone at each treated segment. This segmental technique
signicantly increases the procedure speed and effectiveness in part by eliminating operator variability. A 45-cm
vein can be treated in 3–5 minutes, on par with the fastest
endovenous laser protocol. A shorter 3-cm heating element
design is available for shorter vein segments (Figure 42.2).
The manufacturer currently produces a 60-cm-length
catheter for both sizes of heating elements and a longer
100-cm catheter option for the 7-cm heating element only.
Although there have been signicant changes in design
since the rst RFA device, the present segmental ablation
catheter maintains the temperature feedback loop and thus
controls energy delivery. Impedance is monitored but not
displayed. Displayed on the RFG are the temperature at
the vein wall and the amount of power in watts required
to achieve that temperature. High power (watts) may indicate poor contact with the vein wall, which is likely to
occur with less-than-optimal exsanguination or poor vein
wall compression onto the catheter. In this circumstance,
the generator will display an advisory message prompting
42.2 The 7- and 3-cm-long heating elements of the newer ClosureFast segmental ablation catheter.
42.2 The closure system and RFA procedure 425
https://t.me/med1917
technical correction. The RFG (Figure 42.3) also allows
close control of the temperature range to avoid undesirable
effects of overheating such as boiling, coagulation, vaporization, and carbonization of the tissues. The procedural
steps are quite simple, and, most importantly, there is no
need for continuous pullback of the catheter during energy
delivery. This eliminates most of the variability in energy
delivery to the vein wall, thus ensuring consistent treatment
outcomes.
both local anesthesia for vein access and perivenous tumescent anesthesia, with or without sedation depending on
physician practice and patient anxiety. Percutaneous vein
42.3 The new ClosureFast catheter and radiofrequency generator.
20
The endovenous RFA procedure is performed using
access is performed under duplex ultrasound guidance.
Thermal damage to the vein wall leads to thrombosis and
brosis of the vein and a durable closure of the vein over
time. Less-than-optimal contact between the catheter and
vein wall such as is seen with inappropriate treatment of
aneurysmal segments of vein (>3 cm in diameter) may lead
to supercial phlebitis in the short term and treatment failure in the long term, with restoration of ow and suboptimal clinical outcomes.
42.2.2 Technique of saphenous ablation:
using the segmental ablation
catheter
Once venous access is obtained, a 7-Fr sheath is placed, and
the catheter is inserted through the sheath into the vein to
be treated (Figure 42.4a and 42.4b). Any resistance to catheter passage through the vein should prompt alternative
strategies to navigate venous tortuosity, as this will avoid
patient discomfort and possible vein perforation. Techniques we employ routinely for this situation include gentle
compression on the tissues over or proximal to the catheter
tip to change its direction and/or straightening or bending
of the extremity to change the position of the vein. If these
maneuvers fail, either a standard 0.025-inch or 0.018-inch
guidewire will generally prove successful at crossing the
tortuous segment. If all of these measures are unsuccessful,
a second sheath is placed proximal to the tortuous vein segment. Together, these measures add no signicant morbidity
and very little time to the procedure. Once the entire vein
is traversed with the RF catheter, the tip is pulled back to
a minimum of 2 cm (preferably 3 cm in our practice) from
the SFJ. When treating the small saphenous vein (SSV), the
catheter tip is positioned at the point where the vein begins
to turn down in its course toward the saphenopopliteal
junction. This is usually signicantly more than 2 cm from
42
42.4 (a–i) Procedure technique of radiofrequency ablation using the segmental ablation catheter.
426 Chapter 42 Radiofrequency treatment of the incompetent saphenous vein
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the junction. With the earlier-generation CP catheters, the
tip was often positioned closer to the junction with either
the femoral or popliteal veins because the catheter achieved
lower temperatures than the current technology and, therefore, less forward heating, which can induce the formation
of thrombus (Figure 42.4c and 42.4f).
The key to the performance of almost all in-ofce vein
procedures, other than sclerotherapy, is the use of tumescent anesthesia. This enables the delivery of large amounts
of dilute anesthesia without the risk of lidocaine toxicity.
Consequently, large areas can be anesthetized for treatment. With the RF procedure, tumescent anesthesia is
delivered into the perivenous space (Figure 42.4d–42.4f).
Adequate tumescence (approximately 10 mL/cm vein) is
important for three reasons: rst, it provides vein compression, which improves the vein wall to catheter contact
that is necessary for RF ablation; second, it provides anesthesia and thereby improves patient comfort; and third,
it acts as a heat sink around the treated vein, preventing
thermal injury to the surrounding skin and soft tissues and
nerves. This is reected in the extremely low incidence of
skin burns and paresthesias discussed later in this chapter. With the CLF catheter, energy delivery can be initiated
by pressing a button on the catheter handle rather than
on the generator (Figure 42.4g and 42.4i). This allows
the operator to initiate treatment and eliminates the need
for an assistant for this task, as was necessary with earlier-generation catheters. Gentle external compression over
the heating element is important as an additional measure
to bring the vein wall into contact with the heating element of the catheter and can be achieved with most duplex
probes (Figure 42.4g and 42.4h). With the default setting,
the generator automatically terminates the energy delivery
after 20 seconds. The catheter is then moved to the next
6.5-cm segment for treatment thus allowing for a 0.5 cm
treatment overlap. Shaft markers on the catheter guide the
catheter repositioning during the treatment. An additional
energy cycle is applied at the rst vein segment near the
junction. We will also apply additional treatment cycles to
dilated vein segments and to those areas with signicant
tributaries. After the catheter is moved out of the treatment
zone, it should not be readvanced into an acutely treated
area. Immediate vein wall thickening and vein occlusion
are expected on completion of the treatment.
42.2.3 Postoperative care
Patients are advised to ambulate immediately after the
procedure, and it has been our practice to have patients
wear compression hose for a minimum of 1 week, although
admittedly there is little evidence to support this protocol.
A completion duplex scan is then performed within 72
hours to assess for thrombus extension from the recently
treated supercial vein into the deep system. In 2006, Kabnick et al. identied a new clinical entity named endovenous
heat-induced thrombosis (EHIT) and suggested a protocol
for treatment based on the degree of thrombus extension into the deep venous system.
awareness and treatment modications have reduced the
incidence of clinically relevant EHIT after RFA to between
1% and 2%,
22
with symptomatic pulmonary embolism
21
Subsequent physician
rates reportedly far lower at 0.03%.
23
In 2021 Kabnik et
al. compiled and published the recommendations from the
American Venous Forum and Society of Vascular Surgery
regarding EHIT, standardizing the reporting and treatment
depending on the class. The recommendations also codied
the use of duplex ultrasound for the diagnosis of EHIT.
24
42.3 RF PROCEDURE OUTCOMES
42.3.1 Saphenous vein occlusion
RFA treatment efcacy has been well documented, with
short- to mid-term efcacy rates of 90%–100%.
The published follow-up results are from the VNUS Clinical Registry using rst-generation bipolar technology and
those from the reported latest-generation RF segmental
ablation ClosureFast Registry. Both registries followed
patients for up to 5 years and demonstrated vein occlusion
rates of 87% and 94.9% and reux-free rates of 84% and
91.9%, respectively.
Treatment efcacy with segmental ablation on large-di-
ameter veins has also been evaluated.
33,34
35,36
In 2009, Calcagno
et al. retrospectively reviewed their 6-month saphenous
vein occlusion rates in veins ≤12 mm (mean: 8 ± 2 mm)
against veins >12 mm (mean: 17 ± 4 mm) with the use
of the segmental ablation catheter. Both groups achieved
100% vein occlusion. In 2015, Mese et al. published the
result of a randomized controlled trial of 120 patients
with GSV diameter exceeding 10 mm at the SFJ who qualied for the ablation procedure. The rst 60 patients were
assigned to the EVLA group, and the second 60 patients
were assigned to the RFA group. The authors reported a
successful closure rate of 100% in the EVLA group and
95% in the RFA group, with the difference being not statistically signicant.
36
42.3.2 Clinical outcomes (quality of life
and patient satisfaction)
The treatment of saphenous vein reux by RFA is less painful for patients than conventional surgery, and patients
recover faster. RFA appears to confer a mild benet compared to laser in the early postoperative period, mostly
related to pain, although this is generally short lived. Table
42.1 summarizes patient satisfaction based on randomized
controlled trials comparing RFA to surgery or endovenous
laser. Rautio et al. reported signicantly less postoperative
pain, quantied with a visual analog scale (VAS), in the RF
group compared to the stripping group at rest (P = 0.017),
in a standing position (P = 0.026), and when walking (P =
0.036), with the greatest differences at the 5th to the 14th
postoperative day.
was 0.4 ± 0.49 tablets of 600 mg ibuprofen per day, and
in the stripping group was 1.30 ± 1.09 tablets (P = 0.004).
Sick leaves were also signicantly shorter in the RF group
(6.5 ± 3.3 vs 15.6 ± 6.0 days, P < 0.001), and physical function was restored faster in the RF patients, measured with
RAND short-form 36 QoL questionnaires. A multicenter
study from ve centers in the United States and Europe
(EVOLVeS study) conrmed signicant advantages of the
7
The analgesic needed in the RF patients
7,8,12,14,25–32
42.3 RF procedure outcomes 427
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TABLE 42.1 Effectiveness of radiofrequency ablation for varicose vein symptoms, impact on quality of life, and patient
satisfaction with radiofrequency ablation
Study Treatment
Rautio et al.
Lurie et al.
Lurie et al.
Perala et al.
Hinchliffe et al.
Kianifard et al.
Stötter et al.
Subramonia et al.
Helmy ElKaffas et al.
Kempeneers et al.
Syndor et al.
Lawson et al.
7
8
273c
94d
10
11
14
17
18
(limbs)
CP (15) S&L
(13)
CP (45) 95% 4 months Not signicantly different 3 and 7 days
S&L (36) 100%
CP (36) NR 2 years 1 and 2 years
S&L (29) NR
CP (15) NR 3 years NR
S&L (13) NR
CP (16) 81% 6 weeks
S&L (16) 88%
CP (55) 100% 1 year
S&L (55) 100%
CP (20) 95% 1 year Favored RFA
S&L (20) 100%
13
CP (47) 100% 5 weeks NR
S&L (41) 83%
12
CP (90) 94.5% 2 years Not signicantly different NR
S&L (90) 100%
16
EVLA (140) 96.4% 1 year not signicantly different Not signicantly
RFA (140) 94.5%
EVLA (100) 44 months Not signicantly different Not signicantly
RFA (100)
EVLA (153) 96.7% 60 months Not signicantly different Not signicantly
RFA (158) 96.2%
Early
occlusion rate
NR 8 weeks NR Favored RFA at
Maximum
follow-up
Radiographic or
clinical recurrence 1a
Patient satisfaction
(QoL) 2b
follow-up
different
different
different
8 weeks
42
Abbreviations: QoL: quality of life; RFA: radiofrequency ablation; S&L: stripping and ligation; CP: ClosurePlus; NR: not reported. EVLA: endovenous laser
ablation.
closure procedure compared to conventional surgery, with
less postoperative pain for up to 3 weeks, earlier return to
activities and work, and better cosmetic results. Patients
returned to either normal daily activities or to work at a
mean time of 3 days, 8 days earlier than patients treated
with surgery.
QoL scores were superior in the RFA group at 1 year and
remained signicantly better 2 years after treatment.
8
A 2-year follow-up study showed that
27
Similar clinical outcomes were observed at 2 years with RFA
and surgery, as assessed by CEAP classication and Venous
Clinical Severity Score (VCSS). The newer CLF catheter
appears to confer the same mild convalescence as the previous-generation catheters. The RECOVERY study compared
patient recovery following saphenous RF versus EVLT
with a 980-nm laser ber in the immediate postoperative
period with respect to pain, bruising, and preoperative and
postoperative QoL using the Chronic Venous Insufciency
Questionnaire-2 (CIVIQ-2) tool. Patients treated with RF
did statistically better than EVLT patients in categories of
pain, bruising, and QoL in the early postoperative period.
This benet disappeared at 30 days.
reduction in VCSS at 48 hours (4.7 vs 6.2), 1 week (4.2
vs 5.9), and 2 weeks (4.0 vs 5.3) for RFA as compared to
laser. Reduced pain and postoperative edema were thought
to be the main contributing factors to the improved VCSS
ratings. The difference in VCSS ratings was also limited to
30 days.
8,27,32
A randomized prospective clinical trial published in
2017 by Sydor et al. evaluated the efcacy and safety of
RFA compared to laser ablation, with a 980-nm laser ber,
of the GSV. Two hundred patients were randomized to
receive either RF or EVLA ablation, and clinical and sonographic assessment was performed at 1 week, 6 weeks, and
6 months. Additionally, patients were then followed longterm with a mean follow-up of 44 months for the EVLA
and 42 months for the RF group. Postprocedure pain and
bruising were signicantly lower in the RF group; there
was, however, no signicant difference in adverse effects,
VCSS, or treatment failures in either group. Patients’ satisfaction remained the same between both groups.
32
There was a greater
17
428 Chapter 42 Radiofrequency treatment of the incompetent saphenous vein
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Lawson et al. published a prospective comparative
cohort study evaluating GSV closure using RF-powered
segmental ablation versus EVLA (Varico 2 study) using a
1470 nm diode laser showing similarly high GSV obliteration rates in both groups at 12, 24, 36, 48, and 60 months
as well as similar postprocedure pain and recovery time in
both groups.
18
More recently, a study published by Kempeneers et al.
in 2022 compared 1470 nm EVLA and ClosureFast RF in
280 patients in a prospective, multicenter, randomized trial
over 1 year. There was no statistically signicant difference
between the two groups with respect to occlusion rates,
postprocedure pain, and QOL.
16
42.4 PROCEDURE SAFETY AND
COMPLICATIONS
RFA was the rst endovenous ablation technology available for wide clinical use. The procedure’s safety was
carefully investigated and reported in early and mid-term
publications.
in 1998 to monitor the procedure’s safety and document
treatment outcomes. As experience accumulated, a number
of procedural modications were implemented to minimize
potential risks and increase treatment efcacy. A systematic review conducted by the Ontario Ministry of Health
in 2011 found that approximately 2.9% (105/3664) of
patients who underwent RFA of the saphenous vein had
a major adverse event.
only 13.7% (504) were treated with the newer CLF device.
More recent studies using the CLF catheter report complication rates of <2%, with most complications being minor,
such as skin burns, paresthesias, and thrombophlebitis
(Table 42.2).
42.4.1 Superficial venous
Phlebitis can occur if blood becomes trapped within treated
vein segments and may lead to later vein recanalization at
those sites. It is occasionally seen as a tender, erythematous,
or ecchymotic band over the treated vein, most often in the
thigh where the vein is largest, and is self-limiting, with
treatment needed only for symptom relief. In a compar-
7,8,14,27–29
A clinical registry was established
42
Of all these patients, however,
thrombophlebitis
ative study of 667 RFA procedures, the rate of supercial
venous thrombophlebitis (SVT) was 15% for the original
CP catheter and 10% for the CLF catheter.
38
Similar rates
of SVT were observed in a large randomized controlled
trial comparing 500 patients treated with EVLT, RFA, foam
sclerotherapy, and stripping of the GSV. SVT occurred in
12 patients (9.6%) undergoing RFA.
found a lesser degree of phlebitis after RFA and a reduced
incidence with the newer-generation catheter.
et al. reported a 4% rate of clinically signicant phlebitis
after RFA,
35
and an industry-sponsored multicenter pro-
39
Other studies have
35,40
Calcagno
spective study identied only 2 out of 254 limbs (0.8%)
that had developed clinically signicant SVT after ablation
of the GSV using the CLF catheter.
40
42.4.2 Bruises and burns
With the development of RFA, it became evident that thermal damage would be a major cause of side effects (major or
minor). In early studies, full-thickness skin burns occurred
in between 2%
27
and 4%29 of treated limbs. Tumescent
inltration was introduced to address the skin burn risk.
After the implementation of tumescent anesthesia, and
with appropriate patient selection (see Section 42.5), skin
burns are rarely observed today. Bruising is less frequent
after RFA compared to stripping procedures. In one small,
randomized trial, 16 patients with bilateral recurrent GSV
incompetence after high ligation were randomized to RFA
on one leg versus conventional surgery with stripping of
the GSV on the other leg. Bruising scores were measured
using patient VAS, as well as digital image analysis software, to calculate the percentage of leg discolored after
treatment. After conventional surgery, 21.8% of the leg
was bruised compared to 11.9% (P = 0.02) with RFA using
the CP catheter; in addition, patients perceived less bruising based on a VAS.
10
More recently, this issue was re-examined using the newer CLF catheter in the RECOVERY
study. Moderate-to-severe ecchymosis, dened as >25% of
the treated surface area, occurred in 1 out of 46 (2.2%)
patients using the CLF catheter compared to 21 out of 41
(51.30%) patients treated with a 980-nm laser.
32
42.4.3 Nerve damage and paresthesias
Prior to the routine implementation of tumescent inltration, paresthesia—often described as focal hypoesthesia—
TABLE 42.2 Safety prole of radiofrequency ablation
Complication ClosurePlus (selected studies) ClosureFast (selected studies)
SVT 0.8%–15% [34, 38–40] 0%–10% [36, 38–41]
DVT 0%–3.5% [7, 8, 28, 30, 37, 38] and 16%
PE 0.02% [29] 0% to rare [37]
Thermal injury 0%–4% [29, 37] 0% [37]
Nerve damage and paresthesias (early
and late)
Wound infections 0% to rare [37] 0% to rare [32, 37]
Bleeding 0% to rare [37] 0% to rare [37]
Abbreviations: SVT: superficial venous thrombophlebitis; DVT: deep vein thrombosis; PE: pulmonary embolism.
5a
[42] 0%–1% [38]
9%–19% [7, 8, 14, 25–30] 1%–3.4% [35, 40, 43]
42.5 Contraindications to RFA 429
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was reported in approximately 9%–19% of limbs within
1 week of the procedure, and this gradually resolved over
time.
7,8,14,25–30
It must be noted that not all paresthesias
resolve; the Closure Study Group found a 15% rate of
paresthesias at 1 week (43/286), of which 5.6% (8/142)
persisted at the 2-year follow-up.
inltration effectively eliminates this complication.
33
Perivenous tumescent
27
Limiting treatment to the above-knee saphenous vein also
markedly decreases the risk of paresthesia by avoiding
potential thermal injury to the saphenous nerve, which
most often lies adjacent to the saphenous vein below the
29
If the saphenous vein is to be treated below the
knee.
knee, great care should be taken to administer adequate
tumescent anesthetic and, if possible, to identify the saphenous nerve with duplex and separate it from the vein with
tumescence.
5
42.4.4 DVT and pulmonary embolism
DVT is always a potential risk of any surgical procedure.
In a retrospective study, the incidence of DVT after open
varicose vein surgery was approximately 5.3% in 377
patients.
44
The majority of DVTs in this study were in the
calf and had no evidence of propagation or embolism. The
situation is very different for thrombosis occurring in the
setting of RFA. In the case of endovascular obliteration,
thrombus can originate from the treated supercial vein
and extend into the much larger femoral venous system.
Careful catheter tip positioning is crucial and should be
>2 cm distal to the SFJ and the ostium of the supercial
epigastric tributary. This minimizes the risk of DVT and
preserves physiologic blood ow from the tributary. Immediate and sufcient ambulation is emphasized. The authors
also recommend routine ultrasound scanning within 72
hours of the procedure. DVT rates are reported to be
0%–2% in the majority of published series, which are, for
the most part, with the use of the earlier-generation bipolar
catheters.
(12 of 73), but this is an exception from the experiences
of others.
7,8,14,25–31
42
In one series, the DVT rate was 16.4%
In a comparative study, there were no cases of
DVT detected in those patients treated with the segmental ablation CLF catheter, whereas DVT occurred in 3.5%
of cases treated with the previous-generation bipolar CP
catheters.
38
In a more recent publication by Pannone et
al. evaluating outcome measures of in-ofce endovenous
radiofrequency treatment, the rate of EHIT after the procedure was 1.3% (7 out of 503 limbs treated), and 2 of
those persisted over 6 months of follow-up and were considered a deep vein thrombosis.
45
A large systematic review
by Suarez et al. published in 2023 combined data from
randomized trials and observational studies with more
than 150 patients after thermal and nonthermal ablation.
The review included 31,663 patients and determined the
pooled incidence of EHIT II–IV, DVT, and PE at 1.32%.
The rate of DVT excluding EHIT was 0.2%, and the rate
of DVT was lower in the thermal vs nonthermal ablation
46
group.
42.4.5 Wound infection
Wound infections are very rare complications of endovenous ablative procedures. In the RECOVERY study, for
example, no patient in either group (laser vs RFA) developed a wound infection.
32
42.4.6 Bleeding and hematoma
Risk of bleeding appears to be small and not clinically
signicant in patients undergoing RFA of the saphenous
vein. If there is any bleeding, it is minor and self-limiting.
In one relatively small, nonrandomized, prospective study,
periprocedural bleeding in patients who underwent either
EVLT or RFA while on anticoagulation (n = 88) was compared to that in a control group not on anticoagulation
(n = 92). The authors found that the only group with a
statistically signicantly higher rate of bleeding was the
group undergoing RFA while on “triple therapy” using
aspirin, clopidogrel, and warfarin. No major bleeding
occurred. The study was underpowered to detect a difference between the two different types of ablation tech-
47
niques.
30 cases and no bleeding episodes in 503 limbs treated in
their institution.
Pannone et al. described supercial hematoma in
45
42.5 CONTRAINDICATIONS TO RFA
Despite great enthusiasm regarding RFA for the treatment of GSV reux and varicose veins, there are several
important scenarios in which RFA might be not optimal
or is contraindicated. Small-diameter (<2.5 mm) or tortuous veins, scarred veins, thrombosed veins, and aneurysmal
veins may be contraindications for the RFA procedure, all
for purely mechanical reasons. Acute thrombosis of the
saphenous vein is a contraindication to RFA, as the catheter should not be advanced directly through acute thrombus. In the case of small or tortuous veins, the catheter
may not be able to traverse the lumen. Large aneurysmal
segments of vein will not allow for adequate apposition
between the vein wall and the heating element of the catheter. When treated with RFA, thrombus formation and SVT
often occur. Therefore, aneurysmal segments are best managed by surgical excision. Treatment with RFA of diffusely
enlarged saphenous veins of >2 cm is very uncommon and
prone to fail unless certain measures are taken. Techniques
used to overcome this problem include compression with
ultrasound during heating, use of additional tumescence,
Esmark exsanguination of the leg, adoption of the Trendelenburg position, and/or leg elevation throughout the procedure. In general, we would not recommend RFA for veins
>2.5 cm in diameter. Failure to achieve satisfactory compression should prompt the surgeon to perform an alternative endovenous technique or high ligation and stripping
of the saphenous vein. Patients who have previous chronic
SVT of the saphenous vein who have had excessive scarring and synechiae formation within the vein may not be
candidates simply because the catheter may not be able to
pass through these areas. Another relative contraindication to RFA is a saphenous vein that is very supercial. In
this circumstance, adequate tumescent anesthesia will prevent a skin burn, but will usually not prevent staining and
dimpling of the overlying skin. This should be discussed
in detail with the patient prior to the procedure and a surgical option should be offered. Other contraindications to
42
430 Chapter 42 Radiofrequency treatment of the incompetent saphenous vein
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RFA include pregnancy, inability to ambulate, poor general
health, and acute DVT.
42.6 RECURRENCE RATES AND
TREATMENT FAILURE
Treatment failure can be divided into two groups: hemodynamic failure and clinical failure. Early hemodynamic failure
following surgical stripping is due to incomplete saphenous
vein removal, whereas in the case of RFA, this is due to inadequate vein ablation. Delayed hemodynamic failure after
surgery is primarily due to neovascularization and is recognized as one of the principal causes of recurrent reux and
disease progression after stripping of the saphenous vein.
It occurs in more than 50% of limbs with clinical recurrence
and accounts for 85% of recurrent SFJ reux.
more, 90% of observed neovascularization was already
evident at 2 years.
one (2.8%) RFA limb and four (13.8%) stripped limbs (P
< 0.05) in the EVOLVeS study.
53,54
Neovascularization was reported in
8
A lower incidence of neo-
52,53
48–51
Further-
vascularization with RFA was also reported by Pichot et al.
They carefully studied 63 limbs with a detailed ultrasound
scan protocol and found no evidence of neovascularization
at 2 years after RF treatment. Two major advantages of
RFA that are thought to account for the low incidence of
neovascularization are no incision and surgical dissection of
the groin resulting in angiogenic stimuli and minimal hemodynamic disturbance thanks to preservation of physiologic
epigastric ow through the SFJ. Subsequent to RFA, recanalization of the vein is most often the culprit, but the actual
recurrence of SFJ reux is a more objective measure and
provides important hemodynamic information that permits
the detection and possible prediction of clinical recurrence.
Reux in tributary veins or perforator veins can also cause
hemodynamic failure. Clinical failure occurs when symptoms do not resolve or recur, and is usually associated with
the reappearance of varicose veins. Varicose vein recurrence
rates after vein stripping have been reported in 20%–50%
of limbs at 2–5 years,
some degree of recurrent symptoms by 10 years.
4,52–57
and up to 70% of patients have
58
However,
the varicose vein recurrence rate can be affected by several
factors, including the completeness of varicosity removal at
the time of initial surgery and the examiner’s subjectivity.
Interestingly, 5-year data from the VNUS Closure Registry
revealed that hemodynamic failure did not result in symptom recurrence in most patients.
31
In a more recent study,
however, symptom recurrence (relative risk [RR]: 2.75) and
need for additional procedures (RR: 3.96) did correlate with
recanalization as identied by duplex, but in the 17 out of
249 limbs with recanalization, no anatomic or patient-specic risk factors were found.
59
42.7 OTHER RF DEVICES
42.7.1 RF-induced thermotherapy
RF-induced thermotherapy (RFiTT; Celon AG, Medical Instruments, Teltow, Germany) is a technique that utilizes bipolar RF
via resistive heating of the vein wall (Figure 42.5a,b).
42.5a Celon RFiTT radiofrequency device: the length of the
treatment catheter.
The device uses lower energy than a standard RF cath-
eter (20 J/cm compared to 60–80 J/cm with CLF) (Figure
42.5b).
The benet of the device is adjustable power that
changes automatically as the tissue impedance rises.
6
Laser and RFA Ablation (LARA) study, RFiTT (n = 40)
was compared to EVLT with an 810-nm laser (n = 34).
Occlusion was 95% in both groups at 10 days and 74%
and 78% (P = nonsignicant) at 3 months in the ablation
and laser groups, respectively. In patients who were their
own controls, as they had bilateral disease with one leg
treated by laser and other by RFiTT, postoperative pain
and bruising were signicantly less in the RFiTT legs in
the rst 2 weeks.
ized, multicenter study included 462 patients (569 GSVs),
with follow-up at between 180 and 360 days (mean: 290 ±
84 days). Complete occlusion was accomplished in 98.4%
of patients at a mean follow-up of 290 days when experienced operators performed the procedure.
nos et al. published a prospective, single-center study in
2015 evaluating 168 saphenous veins treated with RFiTT.
The study reported 92% complete occlusion and 7.4%
partial occlusion after mean follow-up of 28 months.
of this writing, the RFiTT catheter is not FDA approved for
saphenous vein ablation.
42.7.2 F Care Systems: endovenous RF
Endovenous RF (EVRF; F Care Systems, Antwerp, Belgium)
is a monopolar RF device that applies continuous energy
for ablation of the saphenous vein using the CR45i catheter
at 4 MHz (25 W). In one unpublished, small, prospective,
nonrandomized study, 30 patients (54 GSVs) were treated
with this technique. At the 1-month follow-up, 92% of
patients had complete occlusion, 6% had partial occlusion
without reux, and 2% had partial occlusion with reux.
Szabó (unpublished data) treated 313 patients (276 GSVs)
in a single-center, prospective study, with early and midterm results showing complete occlusion in 99% (275/276)
of veins at 1 month. Patient satisfaction was 99%, and
there were no major complications such as DVT, thermal
burns, or nerve injury.
tive, randomized trial, 114 patients with saphenous vein
incompetence and varicose veins were treated with either
F Care or ClosureFast catheters. Although VCSS scores
In the
60
A much larger prospective, nonrandom-
61
Hamel–Des-
64
In another, more recent, prospec-
62
As
63
42.5b Celon RFiTT radiofrequency device: the bipolar power control unit.
https://t.me/med1917
42.7 Other RF devices 431
42
42.5c VenClose power adapter unit.
decreased similarly in both groups, 1-year occlusion rates
were 71.7% and 90.6%, respectively (P = 0.013).
42.7.3 VenClose
VenClose (VenClose, Inc., San Jose, CA) is a 6-Fr catheter,
using a segmental type of ablation technology very similar
to that of the CLF catheter, which requires a 7-Fr sheath.
The catheter is more exible than a standard CLF device
and allows for more steerability with a slightly bowed tip.
It allows for toggling between 2.5- and 10-cm treatment
lengths on the same catheter vs the need for two different
65
treatment-length catheters with the CLF device. An approximate 30% reduction in treatment times is also achieved
because of the 10-cm treatment length of the heating element (7 cm for CLF) and no requirement for an overlapping, half-centimeter treatment area with the CLF catheter.
For a 40-cm saphenous vein, average treatment times are
115 s vs 165 s for the CLF catheter (Figure 42.5c).
The device received FDA approval in 2021, and scarce
evidence is available comparing it to standard RFA devices.
Vulakh et al. compared it to a standard RFA device in 503
patients. The success rate was 99.32% at initial follow-up
(3–5 days after the procedure), and the safety prole was
432 Chapter 42 Radiofrequency treatment of the incompetent saphenous vein
https://t.me/med1917
similar to the standard RFA device, with 1.16% rate of
EHIT, 0.38% of DVT, and 3.88% of SVT.
66
The results
of a small, retrospective, matched cohort study comparing consecutive patients with symptomatic saphenous
vein incompetence treated with VenClose to those previously treated with ClosureFast were presented at a recent
regional vascular society meeting. Treatment times and
number of RFA cycles were signicantly less (p < 0.01) for
VenClose-treated patients with no statistically signicant
differences in occlusion or complication rates at 1 and 6
months.
67
42.7.4 Other endovenous or minimally
invasive treatment options
While saphenous RFA combines the benets of a minimally
invasive procedure with excellent clinical outcomes, new
endovenous modalities continue to challenge RFA as the
preferred technique for the treatment of the incompetent,
symptomatic saphenous vein. These include tumescentless
mechanochemical endovenous ablation (MOCA), chemical
and glue ablations, and higher-wavelength laser bers, covered laser bers, and minimally invasive conventional surgical techniques. In one recent small, prospective study of
38 patients using glue–cyanoacrylate embolization (CAE)
with the VenaSeal Sapheon Closure System (Sapheon,
Inc., Morrisville, NC), a 92% target vein closure rate
was achieved without the need for tumescent anesthesia
or postoperative compression stockings. These outcomes
were maintained at the 2-year follow-up.
controlled trial published at the time of the writing of this
chapter describes the immediate 3-month follow-up results
of CAE (n = 108) versus segmental RFA (n = 114). The
study showed noninferiority of CAE to RFA, an adequate
safety prole, less periprocedural ecchymosis, and no need
for tumescent anesthesia.
69
There was no statistical advantage to RFA where periprocedural pain scores were concerned.
MOCA techniques employing the Clarivein Catheter
(Vascular Insights, Madison, CT) use mechanical injury
to the vein endothelium in combination with an infused
liquid sclerosant. Early series have reported decreased
pain and bruising with MOCA, with comparative vein
68
A randomized
occlusion rates to the CLF segmental ablation catheter.
70,71
The Mechanochemical Endovenous Ablation to Radiofrequency Ablation in the Treatment of Primary Great Saphenous Vein Incompetence (MARADONA) trial, published
in 2019, evaluated 213 patients, out of whom 209 were
treated (105 in the MOCA group and 104 in the RFA
group). The study determined that in the short-term postprocedure period MOCA was associated with less pain
but more hyperpigmentation compared to RFA. Faster
improvement in VCSS was noted in the MOCA group.
There were, however, more anatomic failures reported in
the MOCA group, mostly reported as partial recanalization. Both techniques showed similar clinical outcomes at 1
and 2 years.
72
Another study, the Mechanochemical Endovenous Ablation versus Radiofrequency Ablation in the
Treatment of Primary Small Saphenous Vein Insufciency
(MESSI) study for SSV, remains unpublished.
73
42.8 CONCLUSION
Endovenous ablation is now arguably the standard for the
treatment of saphenous vein incompetence. The evidence
for the efcacy—both clinical and anatomic—of RFA of
the GSV is quite robust and is derived from peer-reviewed
journal articles including 17 randomized studies and
their respective mid-term follow-up data. Nine of these
studies compare RFA to open ligation and saphenous
vein stripping,
16–18,31,41,60,74,75
laser.
One trial compares results with all three major endovenous options (sclerotherapy, laser, and RFA) and conventional surgery.
reviewed.
tal ablation has been rapidly adopted by clinicians because
of its proven efcacy, short procedure times, and mild
patient recovery prole as compared to both surgery and
EVLT. Although there are now several additional modes
of endovenous ablation, none have thus far been as thoroughly evaluated and well-studied in the peer-reviewed literature as thermal RFA.
continue to improve the RF procedure for both patients
and those physicians performing the procedure.
7–15
and eight compare RFA to endovenous
39
37,76
These data have been systematically
The most recent-generation RFA by segmen-
77
Newer versions of this modality
Guidelines and Consensus Statements 42.0 of the American Venous Forum on radiofrequency ablation of the
incompetent saphenous vein*
No. Guidelines Grade of
42.1 For patients with symptomatic varicose veins and axial reux in the great saphenous vein
(GSV) who are candidates for intervention, we recommend treatment with endovenous
ablation over high ligation and stripping (HL&S) of the GSV.
42.2 For patients with symptomatic varicose veins and axial reux in the small saphenous vein
(SSV) who are candidates for intervention, we recommend treatment with endovenous
ablation over ligation and stripping of the SSV.
42.3 For patients with symptomatic varicose veins and axial reux in the AAGSV or PAGSV
who are candidates for intervention, we suggest treatment with endovenous ablation,
with additional phlebectomy, if needed, over ligation and stripping of the accessory vein.
recommendation
1
(strong)
1
(strong)
2
(weak)
Quality of
evidence
B (moderate)
C
(low to very
low)
C
(low to very
low)
References 433
https://t.me/med1917
42.4 For patients with symptomatic varicose veins and axial reux in the GSV who place a
high priority on the long-term outcomes of treatment (quality of life and recurrence),
2
(weak)
B (moderate)
we suggest treatment with endovenous laser ablation, radiofrequency ablation, or high
ligation and stripping over physician-compounded ultrasound-guided foam sclerotherapy
because of long-term improvement of quality of life and reduced recurrence.
42.5 For patients with symptomatic varicose veins and axial reux in the SSV, we suggest
treatment with EVLA, RFA, or ligation and stripping from the knee to the upper or mid-calf
over physician-compounded ultrasound-guided foam sclerotherapy because of long-
2
(weak)
C
(low to very
low)
term improvement of quality of life and reduced recurrence.
42.6 For patients with symptomatic varicose veins and axial reux in the AAGSV or PAGSV
who place a high priority on the long-term outcomes of treatment (quality of life and
recurrence), we suggest treatment of the reuxing supercial trunk with endovenous laser
2
(weak)
C
(low to very
low)
ablation, radiofrequency ablation, or high ligation and stripping, with additional phlebectomy, if needed, over physician-compounded ultrasound-guided foam sclerotherapy
because of long-term improvement of quality of life and reduced recurrence.
Consensus Statement
42.7 In patients with an epifascial or supercial saphenous vein, thermal ablation may result in skin burns, hyperpigmentation, or
induration, while nonthermal techniques may cause hyperpigmentation or induration. Mini-phlebectomy or limited stripping is
safe and effective if the saphenous vein is close to the skin (<0.5 cm).
* Based on recommendations of Reference 78.
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TM
ber versus radiofre-
®
42
), in the
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